Class II

Medical Device Recall: Phoroptor VRx Digital Refraction System Model Numbers: 16241

Reichert, Inc. · February 28, 2025

Reason for Recall

The head of the phoropter head could come loose and potentially detach due to a default in the assembly.

Distribution

Domestic: Nationwide Distribution. International: Austria, Bolivia, Canada, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Morocco, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, Slovakia, Switzerland, Thailand, United Arab Emirates, and United Kingdom.

States Affected

NATIONWIDE

Quantity Affected

122 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1500-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Reichert, Inc. Medical Device Recall: Phoroptor VRx Digital Refraction System Model Numbers: 16241 | SafeCheck